Neoplasms

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Cholangiocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

Bile Duct Cancer

patients will be randomized to laparoscopic pancreatoduodenectomy group

Patients will be randomized to Open pancreatoduodenectomy

Open surgery

Laparoscopic surgery

Senthilnathan Palanisamy, MS, DNB

Palanivelu Chinnusamy, MS, MCh

Sandeep Sabnis, MS

The aim of this study is to compare the two surgical approaches namely laparoscopic pancreatoduodenectomy and open pancreatoduodenectomy for management of periampullary and pancreatic head cancers in terms of parameters like hospital stay, pathological radicality, complication rate, peri-operative and post operative outcomes.

Laparoscopic pancreatoduodenectomy (LPD) although technically difficult, requiring high degree of expertise, has shown equal efficacy in terms of complications, oncological safety \& overall outcome to that of open pancreatoduodenectomy (OPD) with advantages of minimally invasive surgery like decreased blood loss, reduced pain, shorter hospital stay \& early return to work.

Although current literature from various centres supports its use, the studies done so far are, case comparisons of either small sample of population or non-randomized trials. According to our knowledge, a randomized trial analyzing open versus laparoscopic pancreatoduodenectomy (PD) in terms of complications and outcome, has not been reported. With this current study we will try to address this issue.

This study is a prospective, randomized, parallel group, controlled trail comparing laparoscopic versus open pancreatoduodenectomy in relation to the hospital stay, peri-operative parameters, pathological radicality \& complications.

This is a single institute based trial, being conducted at GEM hospital and research center, Coimbatore, TN, India. The trial has been approved by the GEM Hospital ethical committee.

Through this trial we are planning to enroll patients having resectable periampullary and pancreatic head malignant lesion at diagnosis. After full assessment, optimization, approval of hospital tumor board with informed consent, those patients selected for surgical therapy with curative intention, will be randomized using computer generated random numbers either into Laparoscopic Pancreatoduodenectomy (LPD) group or Open Pancreatoduodenectomy (OPD) group.

The details of surgery, blood loss, operating time, conversion if any as well as details of postoperative events, hospital stay \& complications if any will be recorded in proforma. Protocols for adjuvant therapy according to pathological stages will be followed. These patients will be reviewed at 1, 3 and 6 months post-surgery.

The primary outcome will be hospital stay at time of discharge or death. The secondary outcomes will be Blood Loss, Operating Time, Complications and pathological radicality at discharge or death. The trial is expected to last for a duration of 2 years.

Pancreatic Head and Peri-ampullary Cancer Laparoscopic vs Open Surgical Treatment Trial (PLOT)

A Prospective Randomized Controlled Trial Comparing Laparoscopic Versus Open Pancreatoduodenectomy for Malignant Periampullary and Pancreatic Head Lesions

Two specimen arms will be compared on the basis of extent of pathological clearance like margin positivity rate, number of lymph nodes, average length of surgical margin

Pancreatic surgery specific complications will be accessed by International Study group for pancreatic surgery ( ISGPS) classification like post operative pancreatic fistula ( POPF). Other complications will be accessed by Clavien Dindo Classification system

GEM Hospital & Research Center

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Infective Agents

Anesthetics

Anti-Bacterial Agents

Somatostatin

Ethanol

Bilirubin

* Preop usual biliary drainage
* Preop smoking and alcohol
* Preop parenteral nutrition
* Oral bowel preparation (mechanical bowel preparation )
* Preoperative fasting \> 12 hours
* Pre-anesthetic medication
* Anti-thrombotic prophylaxis
* Antimicrobial prophylaxis and skin preparation
* Intravenous analgesia : PCA
* Prevention of postoperative nausea and vomiting (PONV) (X)
* Incision : surgeon direction
* Avoiding hypothermia
* Nasogastric intubation (O)
* Postop glycemic control
* Positive fluid balance
* Perianastomotic drain removal over POD #5
* Somatostatin analogues
* Transurethral catheter removal
* Delayed gastric emptying(DGE) (+) , parenteral nutrition (+)
* Postop routine artificial nutrition (O), soft diet at POD #5
* Early and scheduled mobilization

* behavioral intervention (counselling, audit)
* dietary supplement
* procedure (preoperative and postoperative)
* drug

* Preop Counseling
* Preop biliary drainage (X) when Serum Total bilirubin \< 14.62mg/dl and cholangitis (-)
* Preop enteral nutrition
* Oral bowel preparation (mechanical bowel preparation ) (X)
* Preop fasting \< 6 hours
* Prevention of postoperative nausea and vomiting (PONV) (O)
* Nasogastric intubation (X)
* Near-zero fluid balance
* Somatostatin analogues (X)
* Postop routine artificial nutrition (X), soft diet at POD #2
* Audit
* Other items are same as conventional

ERAS perioperative management

Dae Wook Hwang, M.D.

Enhanced Recovery After Surgery (ERAS) is not the program that aim to reduce postoperative hospital stay, but the multimodal strategies that aim to attenuate the loss of, and improve the restoration of,functional capacity after surgery on evidence-based medicine. The benefits of ERAS is proved in many surgical procedures, such as upper gastrointestinal surgery and colorectal surgery. However, pancreaticoduodenectomy (PD, Whipple's operation) is still one of most complex abdominal surgery, and there is no evidence that ERAS is beneficial on PD.

This study investigate the clinical effectiveness of ERAS on PD.

* This study conduct totally 276 patients who underwent PD with borderline or malignant periampullary tumor. The patients divided into two groups. One group take conventional, experienced-based perioperative management, the other group take perioperative management based on ERAS protocol. Applied ERAS protocol is based on "Guidelines for Perioperative Care for Pancreaticoduodenectomy: Ehanced Recovery After Surgery Society Recommendations.
* The outcomes are analyzed for short-term surgical outcomes including operative factors, nutritional status, morbidity, mortality, length of stay, readmission, etc.
* Among all subjects who were randomized and started any study intervention (ERAS or standard perioperative management), the patients who underwent pancreaticoduodenectomy were included as the Full analysis set (FAS). All subjects who didn't undergo pancreaticoduodenectomy were excluded from this study.
* Besides, as all subjects who were randomized and received any study intervention were obliged to follow the study protocol and monitored for best compliance, per-protocol set or safety set were not defined differently

Two study groups (Control (conventional) group and study (intervention) group) were randomly allocated and assigned to one of two groups in parallel for the whole duration of this study.

The evaluation and judgement for morbidity (primary endpoint) / mortality (secondary endpoint) was made by Morbidity and Mortality Committee in our division. Committee members were blinded about knowledge of the interventions assigned to individual participants.

The Effect of ERAS on Pancreaticoduodenectomy

The Effect of ERAS (Enhanced Recovery After Surgery) on Pancreaticoduodenectomy

At initial status of this study, IRB was approved at limited data access only.

The incidence of operation-related morbidity

The incidence of 30 days mortality and in-hospital mortality

The nutritional status would be analyzed by the comparison of PG-SGA score, body mass index and assessment of daily oral intake at preoperative, before discharge and postoperative 2\~3months.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pancreatic Head and Peri-ampullary Cancer Laparoscopic vs Open Surgical Treatment Trial (PLOT)	NCT02081131	Adenocarcinoma ... Cholangio Carci... Duodenal Adenoc... Carcinoma of Am...	Open surgery Laparoscopic su...	30 Years - 70 Years	GEM Hospital & Research Center
The Effect of ERAS on Pancreaticoduodenectomy	NCT02372331	Periampullary T...	ERAS perioperat...	18 Years - 80 Years	Asan Medical Center

Spots Global Cancer Trial Database for whipple's operation