Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Hyperbilirubinemia

Pancreatic Cancer

endoscopic stenting to reduce preoperative jaundice

surgical procedure to decrease preoperative jaundice

Endoscopic stenting to decrease preopertaive jaundice

Endoscopic stenting

cholecystojejunostomy

Tushar K Chattopadhyay, MS

Sundeep S Saluja, MCh

Periampullary carcinoma and carcinoma head of pancreas are common causes of obstruction at the lower end of the common bile duct. Whenever possible, surgical resection in the form of Whipple Pancreaticoduodenectomy (WPD) is the treatment of choice. However, this operation is associated with a substantial postoperative morbidity and mortality. With advances in surgical techniques and postoperative care there has been a decrease in the operative mortality. However, the postoperative morbidity remains high varying between 5%-64%. Of the various risk factors, the degree of jaundice as indicated by the serum bilirubin levels has been associated with an increased risk of complications. Preoperative biliary drainage has been tried to decrease the serum bilirubin levels and consequently decrease postoperative morbidity and mortality. Internal biliary drainage can be achieved by surgical cholecystojejunostomy or endoscopic bile duct stenting. Endoscopic stenting can be done as a day care procedure under conscious sedation, but involves insertion of a foreign body (stent), which results in introduction of bacteria into the bile and problems of postoperative infection. Also, endoscopic stenting before surgery may result in difficulty in dissecting around the common bile duct during the surgical procedure. While the surgical bilioenteric bypass has the advantage that no foreign body is inserted into the biliary tree and hence the likelihood of sepsis is low, it requires anesthesia and involves a surgical incision.

There is no study comparing the outcomes of preoperative endoscopic and surgical drainage in patients undergoing pancraticoduodenectomy. We plan to compare the outcomes of preoperative endoscopic biliary drainage with surgical drainage in patients undergoing pancreaticoduodenectomy.

Hypothesis preoperative biliary decompression by Cholecystojejunostomy will reduce infective complication by 23% as compared to endocopic stenting INTRODUCTION Pancreaticoduodenectomy has been associated with a substantial postoperative morbidity and mortality. Advances in surgical techniques and postoperative care have led to a decrease in the operative mortality. However, the postoperative morbidity has remained high varying between 5%-64%.1 Of the various risk factors, analyzed in the retrospective studies, the degree of jaundice as indicated by the serum bilirubin levels has been associated with an increased risk of complications.2-5 Preoperative biliary drainage has been tried to decrease the serum bilirubin levels and consequently decrease postoperative morbidity and mortality. However, its role remains controversial.

External biliary drainage using percutaneous transhepatic insertion of a catheter has been used.6,7 The disadvantages of external bleary drainage include the risk of spontaneous catheter dislodgement, inflammation and pain at the puncture site, leak of ascitic fluid and bile around the catheter, and loss of fluid and electrolytes. Moreover, bile has an antibacterial action and its loss has been associated with sepsis and renal failure. Hence, internal biliary drainage is considered more appropriate.

Internal biliary drainage can be achieved by surgical cholecystojejunostomy or endoscopic bile duct stenting. The internal drainage provides a more physiological route for drainage of bile into duodenum or jejunum, which prevents any loss of electrolytes and bile salts, and reduces the risk of endotoxemia. Two studies using endoscopic bilary drainage have shown benefit in terms of reduced postoperative morbidity and mortality.7,8 However, it involves the insertion of a foreign body (stent), which results in occurrence of bacteria in bile with its attendant problems of postoperative sepsis.

Prior to the availability of the endoscopic and percutaneous methods, surgical bilioenteric bypass was the only method for preoperative biliary decompression. The disadvantage of this method is that it requires anesthesia and involves a surgical incision. However, its advantages are that no foreign body is inserted into the biliary tree and hence the likelihood of sepsis is low. Also, endoscopic stenting before pancreaticoduodenectomy may result in difficulty while dissecting the common bile duct. Historically, Whipple conceived pancreaticoduodenectomy as a two staged procedure. The first stage was surgical decompression of biliary tract to reduce the level of the hyperbilirubinemia to minimize mortality and morbidity after extirepative surgery and the second stage was a definitive surgical resection.

There is no study comparing the outcomes of preoperative endoscopic and surgical drainage in patients undergoing pancraticoduodenectomy. We plan to carry out a randomized trial comparing the outcomes of preoperative endoscopic biliary drainage with surgical drainage in patients undergoing pancraticoduodenectomy.

AIMS AND OBJECTIVES

To compare endoscopic bilary stenting with cholecystojejunostomy as a preoperative biliary drainage procedure in patients undergoing pancreaticoduodenectomy with respect to

1. Technical success
2. Successful drainage
3. Procedural-related complications
4. Hospital stay
5. Intra-operative difficulty
6. Postoperative morbidity and mortality.

PATIENTS AND METHODS

All consecutive patients with surgical obstructive jaundice attending Gastrointestinal surgery and medicine OPD at AIIMS will be evaluated with a detailed history and clinical examination, liver function tests and an ultrasound abdomen. Those patients who have liver function tests and an ultrasound suggestive of lower end block will be further evaluated with a contrast enhanced CT and side viewing endoscopy (biopsy whenever possible) to characterize the nature of block.

Inclusion criteria

1. Patients with periampullary carcinoma and carcinoma of the head of pancreas.
2. Patients with serum bilirubin \>15mg/dl

Exclusion criteria

1. Patients with gastric outlet obstruction.
2. Patients with unresectable tumour assessed by imaging techniques.
3. Patients with a history of cholecystectomy and Billroth II gastrectomy.
4. Patients stented outside Study design the number of patients to be included was calculated to be 67 in each group based on assumption that infective complications will be reduced to 7%. the sample size was calculated with power of 90% and alpha error of 0.5 Patients will be randomly divided using sealed envelope method (using computer generated random numbers) to two groups of 50patients each.

Group A: Endoscopic stenting Group B: Cholecystojejunostomy

Preprocedural preparation10

1. Informed consent: The patient will be explained about the course and nature of disease, alternatives methods of treatment available, outcome with and without treatment. The procedure will be explained completely to the patient including the risks and complications involved and then consent will be taken.
2. Investigations The following investigations will be done in all the patients

   1. Prothrombin time
   2. Liver function tests (LFTs)
   3. Baseline haematological, biochemical and radiological investigations done in all patients as follows:

   i) Haemogram ii) Kidney Function Test iii) Electrolytes iv) Blood sugar v) Chest X-ray vi) ECG
3. Prophylactic antibiotics: All patients will receive prophylactic antibiotics (Inj cefaperazone + sulbactam 1 gm) 2 hours before the procedure and these will be continued upto 72 hours after the procedure. Patients will be kept nil orally for 8 hours prior to the procedure, and will be well hydrated with i.v. fluids.

Procedure

1. Endoscopic stenting (EBS)11 A therapeutic duodenoscope and a standard sphincterotome will be used for canulation of the bile duct. A hydrophilic guidewire (Terumo, 0.032" dia or Jag wire 0.035" dia, microvasive) will be used to cross the malignant stricture. After the stricture was crossed with the help of a guidewire, the wire will be removed and bile will be aspirated. A small sphincterotomy will be done with a wire-guided sphincterotome to facilitate the passage of the stent. The sphincterotome will be removed and a guide catheter will be passed over the guidewire and then a 10 F 7 cm long straight plastic stent will be inserted across the stricture over the guidewire. A maximum of three attempts will be allowed for insertion of the stent after which it will be categorized as procedural failure.
2. Cholecystojejunostomy (CJ) Cholecystojejunostomy will be done under local anesthesia using a small subcostal incision made over the distended gall bladder. The anastomosis will be done in 2 layers using 3-0 vicryl and 3-0 silk sutures.

Any complications related to both procedures and following them will be recorded.

Follow up On day 5 following the endoscopic or surgical bypass, the patients will be reassessed clinically and with hematological and biochemical parameters with special reference to haemogram and LFTs to know whether the biliary drainage is effective. After 4 weeks along with clinical, hematological and biochemical parameters, nutritional parameters will also be assessed.

All patients will be considered for definitive procedure at least after 4 weeks after the biliary drainage procedure.

The operative difficulty, amount of blood loss, number of transfusions required and operative time during definitive surgery will be recorded. Following pancreaticoduodenectomy, the postoperative complications will be evaluated in both groups.

Outcome measures Primary

1. Technical success: Passage of a stent across the stricture, along with flow of bile through the stent.
2. Successful drainage: A decrease in bilirubin of at least 20% of the pretreatment value within 5 days after procedure
3. Procedure-related complication: was defined complications directly related to stent insertion/CJ
4. Intraoperative assessment: The operative difficulty, amount of blood loss, number of transfusions required and operative time during definitive surgery.

Secondary

1. Procedure-related mortality: was defined as death directly related to complications of stent insertion/CJ
2. Duration of hospital stay: Number of days in hospital from the time of surgery or stenting to initial discharge.
3. Postoperative complication: Complications occurring within 30 days after pancreaticoduodenectomy

   1. Wound infection: presence of purulent discharge with or without growth of microorganism or serous discharge that grows a pathogenic microorganism.
   2. Intra-abdominal abscess: when pus was drained, aspirated or discharged from the peritoneal cavity
   3. Postoperative haemorrhage: Hematemesis, malena, blood los from the abdominal wound or drian site requiring 2 or more units of blood transfusion.
   4. Pancreaticojejunal leak: Drain fluid amaylase level \> 3 times the serum amylase on postoperative day 3 or beyond or percutaneous drainage of amylase rich intra-abdominal collection, with or without clinical sequelae such as fever, leucocytosis, fistula or abscess.
   5. Bile leak: Clinical bile leak or elevated bilirubin level in drain fluid with normal serum level.
4. Postoperative mortality: was defined as death within 30 days after surgery or before discharge from the hospital.

Stastistical analysis Baseline characteristic will be expressed in mean (SD). The Pearson chi square test and Fischer exact test will be used for to compare the categorical data as appropriate. The Student t-test will be used to compare the continuous variables. Multivariate analysis will be done using logistic regression tests. Length of hospital stay will be compared using the log-rank test and the Wilcoxon signed rank test. A pvalue of \<0.05 will be taken as significant.

REFERENCES

1. Sastry RA, Sivam S. Routine preoperative biliary drainage of biliary tree must not be done in patients with obstructive jaundice. Debates in gastrointestinal surgery. Jabalpur- banarsidas Bhanot publishers. 1998:115-62
2. Povoski SP, Karpeh MS Jr, Conlon KC, Blumgart LH, Brennan MF. Association of preoperative biliary drainage with postoperative outcome following pancreaticoduodenectomy. Ann Surg 1999;230:131-42.
3. Grace PA, Pitt HA, Tompkins RK, DenBesten L, Longmire WP Jr. Decreased morbidity and mortality after pancreatoduodenectomy. Am J Surg 1986;151:141-9.
4. Kairaluoma MI, Stahlberg M, Kiviniemi H, Haukipuro K. Results of pancreatoduodenectomy for carcinoma of the head of the pancreas. Hepatogastroenterology 1989;36:412-8.
5. Blenkharn JI, Benjamin IS. Infection during percutaneous transhepatic biliary drainage. Surgery 1989;105:239.
6. Hatfield AR, Tobias R, Terblanche J, Girdwood AH, Fataar S, Harries-Jones R, et al. Preoperative external biliary drainage in obstructive jaundice. A prospective controlled clinical trial. Lancet 1982;23:896-9.
7. Denning DA, Ellison EC, Carey LC. Preoperative percutaneous transhepatic biliary decompression lowers operative morbidity in patients with obstructive jaundice. Am J Surg 1981;141:61-5.
8. Lygidakis NJ, van der Heyde MN, Lubbers MJ. Evaluation of preoperative biliary drainage in the surgical management of pancreatic head carcinoma. Acta Chir Scand 1987;153:665-8.
9. Whipple AO, Parson WB, Mullins LR. Treatment of carcinoma of ampulla of vater. Ann Surg 1935;102:763-9.
10. Gulati MS, Srinivasan A, Agarwal PP. Percutaneous Management of Malignant Biliary Obstruction: The Indian Perspective. Tropical Gastroenterology 2003;24:47-58.
11. Ahuja V, Garg PK, Kumar D, Goindi G, Tandon RK. Presence of white bile associated with lower survival in malignant biliary obstruction. Gastrointest Endosc 2002;55:186-91.

Comparison Between Endoscopic Stenting and Cholecystojejunostomy for PreoperativeDrainage Before Pancreaticoduodenectomy

Passage of a stent across the stricture, along with flow of bile through the stent

A decrease in bilirubin of at least 20% of the pretreatment value within 5 days after procedure

The operative difficulty, amount of blood loss, number of transfusions required and operative time during definitive surgery.

was defined as death directly related to complications of stent insertion/CJ

Number of days in hospital from the time of surgery or stenting to initial discharge.

Complications occurring within 30 days after pancreaticoduodenectomy

presence of purulent discharge with or without growth of microorganism or serous discharge that grows a pathogenic microorganism.

when pus was drained, aspirated or discharged from the peritoneal cavity

Hematemesis, malena, blood los from the abdominal wound or drian site requiring 2 or more units of blood transfusion.

Drain fluid amaylase level \> 3 times the serum amylase on postoperative day 3 or beyond or percutaneous drainage of amylase rich intra-abdominal collection, with or without clinical sequelae such as fever, leucocytosis, fistula

Clinical bile leak or elevated bilirubin level in drain fluid with normal serum level.

All India Institute of Medical Sciences, New Delhi

Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Carcinoma

Urinary Bladder Neoplasms

Jaundice

Jaundice, Obstructive

Gallbladder Neoplasms

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Gallbladder Diseases

Skin Manifestations

Quality of Life

Gallbladder Cancer

percutaneous 10 F stent, endoscopic 10 F stent insertion

Endoscopic biliary stenting, Percutaneous biliary stenting

Peush Sahni, MS, PhD

Sundeep Saluja, MS, MCh

Cancer of the gallbladder (CaGB) is one of the most common causes of malignant obstructive jaundice. Jaundice is the second most common presentation and occurs in 30-60% of patients with CaGB. It is obstructive in nature and frequently associated with pruritus, which is very disturbing for the patients. The usual mechanism of obstruction is direct infiltration of the bile duct by the tumour. Most patients with CaGB with obstructive jaundice are not amenable to a curative surgical resection and hence effective palliation is the goal of treatment. Although surgical bypass has been the traditional palliative approach, it is associated with substantial morbidity and mortality. Non-operative alternatives in the form of percutaneous and endoscopic drainage are available. A few trials have shown that endoscopic drainage is better than percutaneous drainage in patients with lower end bile duct obstruction due to pancreatic and peri-ampullary cancer. However, the scenario is quite different in patients with upper end of bile duct obstruction as occurs due to CaGB. Endoscopic drainage is associated with a higher incidence of cholangitis in patients with a block at the upper end of the bile duct and the success rate varies from 40% to 80%, while percutaneous drainage may be associated with complications such as biliary leak and bleeding. There has been no randomized trial comparing endoscopic and percutaneous drainage in patients with malignant obstruction due to CaGB. The objective of the present study is to carry out a randomized prospective trial comparing percutaneous and endoscopic biliary drainage in patients with CaGB with obstructive jaundice and to assess their quality of life.

Hypothesis: Percutaneous biliary stenting is superior to endoscopic stenting in providing successful biliary drainage by 20% in patients with unresectable malignant hilar block due to carcinoma of gall bladder.

Background: Malignant biliary obstruction at the liver hilum is caused by a heterogeneous group of tumours that include cholangiocarcinoma, gallbladder cancer (CaGB) and metastatic cancer. CaGB is the commonest cause of malignant hilar obstruction in India (1). Jaundice is the second most common presentation and occurs in 30-60% of patients with CaGB (2-5). It is obstructive in nature and frequently associated with pruritis, which is very disturbing for the patients. Most patients with CaGB with surgical obstructive jaundice are not amenable to a curative surgical resection (5) and hence effective palliation is the goal of treatment. Although surgical bilioenteric bypass has been the traditional palliative approach (6), it is associated with substantial morbidity and mortality. Non-operative alternatives in the form of percutaneous and endoscopic drainage are available (7-8). Unilateral drainage of single liver lobe may be sufficient to palliate the jaundice and, pruritis and improve the quality of life (9-15). A few trials have shown that endoscopic drainage is better than percutaneous drainage in patients with lower end bile duct obstruction due to pancreatic and periampullary cancer. However, the scenario is quite different in patients with hilar malignant obstruction. Endoscopic drainage is associated with a higher incidence of cholangitis in patients with a block at the confluence (Bismuth types 2 and 3) and the success rate varies from 40% to 80%, while percutaneous drainage may be associated with complications such as biliary leak and bleeding. There has been no randomized trial comparing endoscopic and percutaneous drainage in patients with malignant hilar obstruction alone.

Objective: To compare unilateral PTBD and endoscopic stenting in patients with CaGB with hilar block in terms of Successful drainage and Quality of life Patients and Methods Consecutive patients with CaGB and jaundice will be enrolled in the study. The diagnosis of CaGB and biliary obstruction will be established on the basis of an ultrasound of the abdomen and a dual phase CT scan. Histological and/or cytological confirmation of the malignancy will be established wherever possible by doing a FNAC/trucut biopsy. Hilar block will be classified according to the Bismuth Corlette classification based on the preprocedural investigations (16). Final differentiation between type 2 and 3 blocks will be based on findings noted during intervention.

Inclusion criteria CaGB with hilar block not suitable for curative resection with one or more of the following criteria: (i) Jaundice with serum bilirubin \>10 mg/dl, (ii) Pruritus, (iii) Cholangitis Exclusion criteria: Poor performance status: Karnofsky index \< 60, Type 1 and 4 hilar block, Uncontrolled ascites, Duodenal obstruction, Patients who opted for insertion of a metallic stent.

Sample size calculation: The number of patients to be included was calculated to be 91 patients in each group based on the assumption that percutaneous drainage will be better than endoscopic drainage by 20 %. The sample size was calculated by the formula for a power of 80% and alpha error of 0.05.

The patients will be randomly divided into two groups using random blocks generated by a computer.

Group A - percutaneous biliary drainage (PTBD) Group B - Endoscopic stenting (ES) Pre-procedural preparation(17) Patients will undergo detailed investigations and an informed consent will be obtained.

The procedure will be performed under conscious sedation (midazolam and pentozocine) with a liberal infiltration of local anesthetic at the site and the capsule of the liver for PTBD.

1. PTBD procedure (17) Either a right or left sided approach will be used for PTBD. Once entry will be gained to a suitable duct the standard Seldinger technique will be used to place a guidewire in the biliary system. The tract will be dilated and after crossing the obstruction with a hydrophilic guidewire, a ring biliary catheter will be placed to provide internal-external drainage. In a subsequent session, a 10 F, straight plastic stent (polyurethane) will be placed into the system across the obstruction to provide internal drainage.
2. Endoscopic stenting (18) A therapeutic duodenoscope and a standard sphincterotome will be used for cannulation of the bile duct. A hydrophilic guidewire will be used to cross the malignant stricture. After the stricture is crossed a guide catheter will be passed over the guidewire and then a 10 F straight plastic stent will be inserted across the stricture over the guidewire.

Primary outcome measures:

1. Successful drainage: A decrease in bilirubin to less than 75% of the pretreatment value within 7 days
2. Early cholangitis: Occurring within 48 hours to 7 days of the procedure as evidenced by fever, leukocytosis and worsening LFTs.
3. Quality of life

Secondary outcome measures:

1. Complications
2. Procedure-related and 30-day mortality
3. Stent patency time will be defined by time to stent occlusion.

Hematological and biochemical parameters will be assessed at days 2 and 7, 1 month after stent placement and every 3 months thereafter. Patients will be re-evaluated 7 days, 1 month after stent placement and 3 months thereafter.

Quality of life will be assessed using the WHO-QOL BREF26 and EORTC QLQ-30 questionnaires pre-procedure, at 1 month and at 3 months.

World Health Organization-QOL BREF-26 (19) This has 26 items, which cover physical, psychological, social and environmental domains. The daily activity is graded in accordance with the 5 grade scale of performance status recommended by the WHO. WHO-QOL domain scores will be calculated using the guidelines given in the WHO-QOL scoring manual. A high score represents a high level of QOL.

EORTC QLQ-30 (20) The EORTC QLQ-30 consists of 30 generally applicable items. It incorporates a functional scale (items 1-5), a role functioning scale (item 6,7), a general symptom scale (item 8-19), scales on cognitive (item 20-25), emotional (items 21-24) and social (items 26-27) functioning, financial strain scale (item 28) and global health status scale (item 29,30). Scoring will be done using the EORTC scoring manual.

A high score for a functional scale will represent a high/healthy level of functioning, a high score for global health status/QOL will represent high QOL but a high score for symptom scale/item will represent a higher level of symptomatology/ problem.

All patients will be instructed to contact the department, if any symptom suggestive of a complication appeared. Additional information regarding current status or death will be obtained by direct contact with the referring physician or the patient by telephone/letter.

Statistical analysis Data will be analyzed according to both the intention-to-treat (ITT) and per protocol (PP) methods. The baseline characteristics will be expressed in mean (SD). The Pearson chi -square test and Fischer exact test will be used for comparison of categorical data as appropriate. The t-test will be used for comparison of continuous variables. Cumulative survival will be estimated using Kaplan-Meier life table analysis, and the groups will be compared by log rank chi-square test.

The QOL score analysis will be done using Paired 't' test for comparison between baseline and 1 month and baseline and 3 months within the groups. MANOVA will be used to assess the trend of the scores.

References

1. Malkan G, Mohandas KM. Epidemiology of digestive cancers in India. I. General principles and esophageal cancer. Indian J Gastroenterol 1997;16(3):98-102
2. Wanebo HJ, Castle WN, Fechner RE. Is carcinoma of the gall bladder a curable lesion? Ann Surg 1982;195:624-31.
3. Kelly TR, Chamberlain TR. Carcinoma of the gall bladder. Am J Surg 1982; 143:737-41
4. Morrow CF, Sutherland DE, Florack G, Eisenberg MM, Grage TB. Primary carcinoma gall bladder: Significance of subserosal lesions and results of aggressive surgical treatment and adjuvant chemotherapy. Surgery 1983;94:709-14
5. Kumaran V, Gulati MS, Paul SB, Pande GK, Sahni P, Chattopadhyay TK. The role of dual phase helical CT in assessing respectability of carinoma of the gall bladder. Eur Radiol 2002;12:1993-99.
6. Bismuth H, Castaing D, Traynor O. Resection or palliation; priority of surgery in the treatment of hilar cancer. World J Surg 1988; 12:39-47.
7. Huibregtse K, Tytgat GNJ. Palliative treatment of jaundice by transpapillary introduction of biliary endoprosthesis. Gut 1982; 23:371-5.
8. Cotton PB. Endoscopic methods for relief of malignant obstructive jaundice. World J Surg 1984;8:854-61.
9. Dowsett JF, Vaira D, Hatfield AR, Cairns SR, Polydorou AA, Frost R, et al. Endoscopic biliary therapy using the combined percutaneous and endosopic route. Gastroenterology 1989;96:1180-6.
10. Polydorou AA, Cairns SR, Dowsett JF, Hatfield AR, Salmon PR, Cotton PB, et al. Palliation of proximal malignant biliary obstruction by endoscopic endoprosthesis insertion. Gut 1991;32:685-9.
11. De Palma GD, Galloro G, Sicilliano S, Ivonini P, Catanzano C. Unilateral versus bilateral endoscopic hepatic duct drainage in patients with malignant hilar biliary obstruction: results of a prospective, randomized and controlled study. Gastrointest Endosc 2001;53:547-53
12. Sherman S. Endoscopic drainage of malignant hilar obstruction: is one biliary stent enough or should we place two? Gastrointest Endosc 2001;53:681-4.
13. Chang WH, Kortan P, Haber GB. Outcome in patients with bifurcation tumors who undergo unilateral versus bilateral hepatic duct drainage. Gastrointest Endosc 1998;47:354-62
14. Mehta S, Ozden ZS, Dhanireddy S, Pleskow DP, Chutanni R. Endoscopic single versus double (bilateral) Wallstents for palliation of malignant Bismuth type III/IV hilar strictures: comparison of clinical outcomes and costs (abstract). Gastrointest Endosc 1999;49:AB234.
15. De Palma, Angelo Pezzullo, Maria Rega, Unilateral placement of metallic stents for malignant hilar obstruction: a prospective study. Gastrointest Endosc 2003;55:50-5.
16. Bismuth H, Castaing D, Traynor O. Resection or palliation :priority of surgery in the treatment of hilar cancer. World j Surg 1988;12:39-47.
17. Gulati MS, Srinivasan A, Agarwal PP. Percutaneous Management of Malignant Biliary Obstruction: The Indian Perspective. Tropical Gastroenterology 2003;24:47-58.
18. Ahuja V, Garg PK, Kumar D, Goindi G, Tandon RK. Presence of white bile associated with lower survival in malignant biliary obstruction. Gastrointest Endosc 2002;55:186-91.
19. World Health Organization Handbook for Reporting Results of cancer Treatment. World Health Organization Publication No .48 Geneva World Health Organization 1979.
20. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85:365-76.

Endoscopic Versus Percutaneous Drainage For Hilar Block in Gall Bladder Cancer

Endoscopic Versus Percutaneous Biliary Drainage For Hilar Block Due to Carcinoma Gall Bladder: A Randomized Prospective Trial and Quality Of Life Assessment

VP Gupta

Cholestasis

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary)

Endoscopic biliary stenting using metal stent (completed by duodenal stent, if necessary)

Surgical bypass

Placement of a biliary metal stent (in combination with a duodenal metal stent in case of gastric outlet obstruction if necessary)

Bruno Schmied, MD

The prognosis of patients with unresectable pancreatic cancer is dismal. Hence, palliation of tumor-associated symptoms, in particular jaundice due to low bile duct obstruction and gastric outlet obstruction, is the primary aim of these patients' care. Endoscopic stenting and surgical bypass are currently the two competing treatment options. There is currently no randomized trial comparing the recently developed metal stents to surgical bypass. Furthermore, there is very limited data on quality of life of these patients receiving either therapy. While endoscopic stenting represents the less invasive treatment, surgery may provide better long-term control requiring one-time treatment. Due to the incomplete evidence the present randomized controlled trial is designed to compare quality of life of patients undergoing endoscopic stenting on demand or surgical bypass for palliation of symptoms caused by cancer of the pancreatic head requiring with low bile duct obstruction.

Endoscopic Stenting Versus Surgical Bypass for Low Bile Duct Obstruction by Cancer of the Pancreatic Head

Endoscopic Biliary Stenting on Demand Versus Surgical Biliary Bypass for Palliation of Patients With Advanced Cancer of the Pancreatic Head: STENTBY - A Randomized Controlled Trial

Heidelberg University

Constriction, Pathologic

Truls Hauge, MD,PhD

Obstruction of the digestive tract is a frequent cause of morbidity in patients with gastrointestinal cancer.Palliative endoscopic treatment with self- expanding metal stents(SEMS)is an alternative to palliative surgery and other palliative treatment options.The method has expanded to include patients with malignancies in the esophagus,gastroduodenal region, biliary tractus and colon. Numerous retrospective studies have reported treatment with SEMS to be safe and effective. Prospective studies,and especially studies regarding Quality of Life improvement are needed.

PURPOSE:

The purpose of this trial is to prospectively study the use and effect of selfexpanding metal stents(SEMS)in a defined population i Norway, especially Quality of Life changes.

The study is divided into four projects:

1. Establish a central register over all patients with malignant GI-obstruction who are treated with SEMS in the Eastern health region in Norway .Treatment incidence, methods used, treatment effect,complications related to the procedure,Need for reinterventions, hospitalisations and survival will be studied.
2. Quality of life(QoL) studies will be performed before and 14 days after treatment.The EORTC QLQ C30 and EORTCs organospecific modules will be used.
3. Gastric emptying before/after stent will be studied.
4. Evaluate SEMS treatment of acute colon obstruction, as a permanent palliative treatment or as a "bridge to surgery"

Endoscopic Stenting of Gastrointestinal Cancer

Palliative Endoscopic Treatment of Malignant GI-strictures With Self Expanding Metal Stents(SEMS)-a Prospective Multicenter Study

Ullevaal University Hospital

Ear, Nose, and Throat Diseases

Mouth and Tooth Diseases

Adenocarcinoma

Deglutition Disorders

Esophageal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Esophageal Diseases

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Head and Neck Neoplasms

Esophageal Cancer

Single dose of 12 Gy generated using a flexible applicator containing Iridium 192 with the range of irradiation of 1cm from the applicator axis. The extent of irradiation will cover the whole length of cancer stricture and 2cm beyond proximal and distal end of the tumor.

Endoscopic stenting with partially covered selfexpandable metalic stents positioned across the cancer stricture and extending 2cm proximally and 2cm distally to the proximal and distal end of the tumor, respectively

Brachytherapy

Tomasz Skoczylas, MD, PhD

Krzysztof Zinkiewicz, MD, PhD

Witold Zgodziński, MD, PhD

Marek Majewski, MD, PhD

Grzegorz Wallner, Professor

Andrzej Dąbrowski, Professor

Witold Krupski, Professor

Dariusz Kieszko, MD, PhD

Elżbieta Starosławska, MD, PhD

Paweł Cisek, MD

Krzysztof Paprota, MD, PhD

Tomasz Kubiatowski, MD, PhD

Bożena Kukiełka-Budny, MD, PhD

The objective of the study is comparison of the efficacy and safety of palliative therapy with single-dose brachytherapy or selfexpanding metal stents (SEMS) in malignant dysphagia resulting from adenocarcinoma of the esophago-gastric junction.

Over the past two decades it has been observed a clear trend in the increasing incidence of adenocarcinoma of the esophagus and esophago-gastric junction. More than half of these patients already have inoperable disease at presentation. Most of them need palliative treatment to relieve progressive dysphagia. Presently, endoscopic placement of a covered selfexpanding metal stent is the most commonly used method for treatment of malignant dysphagia. Cancer overgrowth and stent migration are the most common complications of endoscopic stenting and they occur more frequently with longer time from stenting. Specific location at esophago-gastric junction at the end point of the propulsive force after swallow may predispose stents for easier migration to the stomach. Additionally, the advances in chemotherapy have resulted in improved median survival of advanced adenocarcinoma ot the stomach and esophago-gastric junction even up to 10-12 months increasing a potential for higher chance for occurrence of stent complications. Brachytherapy has been proved to be a valuable and durable method to treat malignant dysphagia resulting from esophageal and mainly squamous cell cancer. For many years irradiation was not recommended for adenocarcinoma of the esophagus and esophago-gastric junction due to their putative low sensitivity to radiotherapy. Recently external beam radiation has been incorporated to a combined modality therapy regimens also for adenocarcinoma of the esophagus. Thus, brachytherapy could be an attractive and durable method for improving swallowing in adenocarcinoma of the esophago-gastric junction, as well. Single-dose brachytherapy and endoscopic stenting with SEMS in relieving dysphagia resulting from clearly defined adenocarcinoma of the esophago-gastric junction have not been compared yet.

Comparison Study of Brachytherapy and Endoscopic Stenting for Dysphagia in Esophago-Gastric Junction Cancer

The Comparison of Value of Brachytherapy and Endoscopic Stenting With SEMS in Palliative Treatment of Dysphagia Resulting From Adenocarcinoma of the Esophago-Gastric Junction

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison Between Endoscopic Stenting and Cholecystojejunostomy for PreoperativeDrainage Before Pancreaticoduodenectomy	NCT01913275	Periampullary C... Pancreatic Canc...	Endoscopic sten... cholecystojejun...	18 Years - 80 Years	All India Institute of Medical Sciences, New Delhi
Endoscopic Versus Percutaneous Drainage For Hilar Block in Gall Bladder Cancer	NCT00409864	Gallbladder Can... Obstructive Jau...	Endoscopic bili...	18 Years - 80 Years	All India Institute of Medical Sciences, New Delhi
Endoscopic Stenting Versus Surgical Bypass for Low Bile Duct Obstruction by Cancer of the Pancreatic Head	NCT00753441	Pancreatic Canc...	Surgical bypass Endoscopic sten...	18 Years -	Heidelberg University
Comparison Between Endoscopic Stenting and Cholecystojejunostomy for PreoperativeDrainage Before Pancreaticoduodenectomy	NCT01913275	Periampullary C... Pancreatic Canc...	Endoscopic sten... cholecystojejun...	18 Years - 80 Years	All India Institute of Medical Sciences, New Delhi
Endoscopic Stenting of Gastrointestinal Cancer	NCT00422409	Gastrointestina... Biliary Tract N...	Endoscopic sten...	18 Years -	Oslo University Hospital
Endoscopic Versus Percutaneous Drainage For Hilar Block in Gall Bladder Cancer	NCT00409864	Gallbladder Can... Obstructive Jau...	Endoscopic bili...	18 Years - 80 Years	All India Institute of Medical Sciences, New Delhi
Comparison Study of Brachytherapy and Endoscopic Stenting for Dysphagia in Esophago-Gastric Junction Cancer	NCT01786278	Adenocarcinoma ...	Brachytherapy Endoscopic sten...	18 Years -	Medical University of Lublin

Spots Global Cancer Trial Database for endoscopic stenting