Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Double tract reconstruction would be applied after proximal gastrectomy

Gastric conduit reconstruction would be applied after proximal gastrectomy

Other reconstructions except for double tract and gastric conduit reconstructions would be applied after proximal gastrectomy

Double tract reconstruction would be applied after radical proximal gastrectomy.

Double tract reconstruction

Gastric conduit reconstructionn would be applied after radical proximal gastrectomy.

Gastric conduit reconstruction

Other reconstructions except for double tract and gastric conduit reconstructions would be applied after radical proximal gastrectomy.

Other reconstructions

Ping Shu, PHD

This study is designed as a prospective, real world registry study that compare the safety and efficacy of the different construction methods after radical proximal gastrectomy.

* The patient was admitted to the hospital, and at the time of physical examination, the following conditions were met: 18 years old ≤ age ≤ 80 years old; preoperative ECOG performance status score 0/1; non-pregnant or lactating women; no serious mental illness; no serious respiratory disease; No severe hepatic and renal insufficiency; no history of unstable angina pectoris and myocardial infarction within 6 months; no history of cerebral infarction or cerebral hemorrhage within 6 months, except for old cavity infarction; no history of continuous glucocorticoid therapy (local Except for applications); pulmonary function test showed FEV1 ≥ 50% of the predicted value. The patient did not participate in other clinical studies (within 6 months).

  * gastric adenocarcinoma was diagnosed by endoscopic examination and histopathological biopsy of the patient's primary lesion, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly adherent carcinoma (including signet ring cell carcinoma and other types), Mixed adenocarcinoma, etc. In qualified units, endoscopic ultrasonography (EUS) is recommended. The tumor is located in the upper part of the stomach or at the esophagogastric junction (tumor diameter is less than 4cm, and the length of invasion of the esophagus is less than 2cm);

    * Enhanced CT scan of the abdomen and pelvis was performed on the patient. For upper gastric cancer, no tumor invading the muscular layer, subserosal layer or serosa layer was found, and no distant metastasis occurred; for esophagogastric junction cancer, no distant metastasis occurred;

      * The patient has a clear diagnosis of gastric adenocarcinoma, and it is expected that proximal gastrectomy and lymph node dissection can be performed to obtain an R0 surgical result. .

        * The patient's ASA is I-III. ⑥ At this point, the patient becomes a potential selected case and enters the case selection procedure.

A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal Gastrectomy

Reflux esophagitis refers to esophageal erosions and/or esophageal ulcers caused by the reflux of esophageal contents into the esophagus or above (oral mouth, throat, lungs) causing complaints of discomfort and endoscopic manifestations of esophageal mucosal defects.

Take the total number of patients receiving surgical treatment as the denominator, and the number of patients with intraoperative/postoperative early and late complications during any one and follow-up as the numerator to calculate the proportion;

Body weight(kg)would be monitored during follow-up after surgery.

Albumin(g/L) would be monitored during follow-up after surgery.

Hemoglobin(g/L) would be monitored during follow-up after surgery.

The time between the date of surgery as the starting point and the date of tumor recurrence as the ending point (or the date of death due to tumor cause when the exact date of tumor recurrence is not known).

When neither death nor tumor recurrence was observed at follow-up, the final date of confirmation of recurrence-free survival (final recurrence-free survival confirmation date: the last of the date of the outpatient visit or the date of the examination received) was used.

Taking the total number of patients receiving surgical treatment as the denominator, and observing any of the following patients as the numerator, the ratio calculated as the surgical death ratio:

1. According to the observation items during the operation and the observation items after the operation, it will be recorded as death;
2. All patients who died from the start of the operation to within 30 days after the operation (including 30 days) (regardless of whether the cause of death was causally related to the operation);
3. In a longer period of time after 31 days after the operation, there is definite evidence that the death of the patient has a direct causal relationship with the first operation.

Shanghai Zhongshan Hospital

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Gastroesophageal Reflux

Esophagitis

Esophagitis, Peptic

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

LAPG : laparoscopy-assisted proximal gastrectomy with double tract reconstruction group

LATG : laparoscopy-assisted total gastrectomy group

Laparoscopy-assisted proximal gastrectomy versus Laparoscopy-assisted total gastrectomy

Laparoscopy-assisted gastrectomy

Hyung-Ho Kim, M.D., Ph.D.

The choice of surgical strategy for patients with proximal gastric cancer is controversial mainly because proximal gastrectomy is infamous for high rates of reflux symptoms and anastomotic stricture. but there are no prospective randomized trials until now.

The primary end point of this study is whether the rate of reflux esophagitis is different or not between LAPG and LATG. Through this study, we

Prospective Randomized Clinical Trials between Laparoscopy-assisted Proximal Gastrectomy and Laparoscopy-assisted Total Gastrectomy.

LAPG reconstruction: double tract reconstruction (3 anastomosis, intracorporeal Roux-en Y esophago-jejunostomy, extracorporeal gastro-jejunostomy 10cm below esophago-jejunostomy,extracorporeal jejuno-jejunostomy 20cm below gastro-jejunostomy)

LATG reconstruction: intracorporeal Roux-en Y esophago-jejunostomy

Primary end point : incidence of reflux esophagitis after operation

Sample Size : LAPG 97 cases, LATG 97 cases (p1=0.018 p2=0.018, a=0.05, b=0.80) Non-inferiority test, non-inferior margin (delta) : 0.05. Sample size calculated by our MRCC(Medical Research Collaborating Center, http://mrcc.snubh.org)

Study duration : 48 months (enrollment 36months, follow-up 12months)

Reflux esophagitis evaluation methods

1. Ambulatory 24hr-pH esophageal holter monitoring for acid reflux
2. DISIDA scan for bile reflux
3. Endoscopic evaluation (Grading according to LA classification)
4. Visick score (subjective symptoms)
5. EORTC sto 22 and GIQLI evaluation (Quality of Life)
6. Nutritional Benefits (Body weight, Triceps Skin folds Thickness, Blood test)
7. Upper gastrointestinal study
8. Gastric emptying scan

Laparoscopy-assisted Proximal Gastrectomy Versus and Laparoscopy-assisted Total Gastrectomy

Phase III Prospective Randomized Clinical Trial of Laparoscopy-assisted Proximal Gastrectomy (LAPG) and Laparoscopy-assisted Total Gastrectomy (LATG) for Upper Gastric Cancer. (Multicenter Study)

Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score

Seoul National University Bundang Hospital

Professor

Heart and Blood Diseases

Heart Valve Diseases

Patients who meet the inclusion criteria will undergo ThTV anastomosis after proximal gastrectomy

The ThTV esophagogastrostomy procedure involved placing a lengthy gastric tube into the lower mediastinum, firmly bound to the esophagus.

the Transhiatal Tunnel Valvuloplasty technique

Dongbing Zhao

Dongbing R Zhao, M.D.

Patients who meet the inclusion criteria will undergo laparoscopic proximal gastric cancer radical surgery, and esophagogastric anastomosis will be performed using the ThTV method.

Review the surgical video and record the time for making the extracorporeal muscle flap, tunnel passage time, and anastomosis time. The production time of the muscle flap is based on the electric knife incision of the muscle flap as the starting point, and successfully penetrating the muscle flap as the endpoint. The tunnel passes through time, pulling the residual end of the esophagus, and starting to pass through the gastric muscle flap tunnel as the time starting point. The complete placement of the gastric tube into the lower mediastinum is used as the time endpoint. The anastomosis time is calculated from the first needle of suturing the residual stomach and the posterior wall of the esophagus until the end of the plasma flap suturing. Record perioperative indicators such as surgical time, bleeding volume, and postoperative hospital stay. The definition of anastomotic stenosis is that in gastroscopy, those who cannot pass through the anastomotic site with ultra-fine endoscopy are judged as anastomotic stenosis.

Postoperative pathology was performed using the 8th edition AJCC staging. Follow up every three months after surgery, including blood tests, liver and kidney function, and tumor markers. According to the situation, choose gastroscopy, upper gastrointestinal imaging, and chest abdominal pelvic enhanced CT. Evaluate postoperative reflux symptoms such as heartburn and sternal pain using the Visick grading system. Gastroscopy Los Angeles grading was used to evaluate postoperative reflux esophagitis.

Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy

Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy，Phase II Trial

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Clinical Professor

Behaviors and Mental Disorders

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Quality of Life

Esophageal Cancer

Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique

Surgical Operation:

1. Gastric Resection Range:Proximal gastrectomy, preserving 2/3 of the distal stomach.
2. Lymph Node Dissection Range:D1+ to D2 lymph node dissection.
3. Anastomosis Method: esophagogastrostomy by fissure technique.
4. Anastomosis Risk Management Plan:For a rupture with a maximum diameter less than or equal to 5mm, repair with 4-0/3-0 absorbable sutures and proceed with the anastomosis.For a rupture with a maximum diameter greater than 5mm or failed anastomosis, resect that part of the remaining stomach, change to proximal gastrectomy, and perform double-channel anastomosis.
5. Surgical Approach:Totally laparoscopic proximal gastrectomy.

Hankun Hao, doctor

This is a single-center, open-label, Phase Ib/II study aiming to assess the perioperative safety and postoperative outcomes of a novel surgical technique in treating primary adenocarcinoma located in the upper 1/3 of the stomach or gastroesophageal junction (Siewert II or III).

The study will enroll 30 patients who will undergo totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique. Clinical data will be collected to evaluate perioperative safety. Patients will be followed for at least 3 months, during which endoscopy will be performed to analyze occurrences and reasons for anastomotic-related complications. Additionally, the quality of life after surgery will be evaluated by QLQ-C30 and QLQ-STO22.

Patients included in this group will receive totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique，which is an innovative surgery that investigators first began to apply in patients with proximal gastric cancer.

A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique

A Prospective Study on the Perioperative Safety and Short-Term Quality of Life in Totally Laparoscopic Proximal Gastrectomy With Esophagogastrostomy by Fissure Technique

Time spent on the whole operation（minutes）

Time to remove the drain tube,flatus, to liquid diet, and soft diet are used to assess the postoperative recovery course, which is a composite outcome measure.

AJCC（American Joint Committee on Cancer）-8th TNM staging system will be used to obtain pathology of tumor .

Patients will be monitored for the incidence of postoperative reflux esophagitis after surgery by weight changes, blood biochemistry and endoscopic examination

QLQ-C30 is a comprehensive assessment of the overall quality of life dimensions before and after surgery for patients. Higher scores represent poorer quality of life for patients after surgery.

QLQ-STO22 is a specific assessment for postoperative situations related to anastomosis, such as swallowing and eating.Higher scores represent poorer quality of life for patients after surgery.

Huashan Hospital

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Methylene Blue

Standard procedure: Patient placed in a supine position and proximal gastrectomy performed under general anesthesia.

1. Lymph node dissection
2. Cut the esophagus
3. Gymnosis of gastric curvature greater and gastric curvature lesser
4. The specimen removed from the stomach(5cm away)
5. Preparation of serosa-muscle flap: Mark two straight lines, A and B, about 3cm long, with methylene blue on the anterior wall of the stomach about 2cm and 6cm from the gastric stump. The electrocoagulation and cutting power of the electrotome were adjusted to 10 watts, and the serosa-muscle layer of the gastric wall was cut along the marked line with the electrotome. With the help of the assistant, the surgeon separated the gastric parietal serosa-muscle layer from the submucosa along line B to line A. When the dissociation reached the middle point of the tunnel, it should be dissociated along line A to line B, completely dissociated the gastric parietal serosa-muscle layer from the submucosa.

Suture the gastric remnant at the mark on the back wall of the esophagus.(Don't tighten the suture); Pull the esophageal stump out of the tunnel meanwhile tighten the suture and the gastric stump to close the back wall of the esophagus and the gastric stump together;Cut the back esophageal wall close to the esophageal stump,cut the front gastric wall along line B. Suture the back esophageal wall and the upper edge of the front gastric wall incision from right to left;Remove residual esophageal nail, and suture the back esophageal wall and the lower edge of the gastric incision from right to left. Suture the anterior wall of the stomach at the lower edge of the tunnel with the serosa layer at the lower edge of the front wall of the esophagus stomach anastomosis;Suture the upper edge of the tunnel with the front wall of the esophagus and the left and right lateral walls at the gastric stump suture of the original posterior wall of the esophagus. (all use 3-0 barbed suture continuously)

PTST(parachute-tunnel-style technique)for esophagogastrostomy

1. To evaluate the safety, simplicity and effectiveness of the gastric function (anti-reflux) preservation of the innovative "parachute-tunnel-style technique" (PTST) in laparoscopic proximal gastrectomy.
2. To investigate the correlation between anastomotic stenosis and blood supply of serosa-muscle flap,suture after esophagogastric anastomosis.(obtain objective indexes such as blood supply, healing pattern and length change of serosa-muscle flap through animal experiments)

A Clinical Study of Laparoscopic Proximal Gastrectomy Based on PTST(Parachute-tunnel- Style Technique) Esophagogastric Anastomose.

A Single-center, Prospective, Single-arm Clinical Study of Laparoscopic Proximal Gastrectomy Based on an Original Esophagogastric Anastomose (PTST,Parachute- Tunnel- Style Technique)

* Visick score after surgery
* Los Angeles rating

Tang-Du Hospital

Symptoms and General Pathology

Gastritis

Gastroenteritis

Peptic Ulcer

Ulcer

Duodenal Diseases

Intestinal Diseases

Patients in the Group B will received the double-track anastomosis with proximal gastrectomy.

Patients in the Group A (Gastric tube anastomosis) will take the gastric tube anastomosis with proximal gastrectomy.

In the gastric tube group, the lesser curvature of the gastric remnant approximately 3 cm proximal to the pylorus was removed first by a linear stapling device. An approximately 5-cm-wide tubular stomach was then constructed with preserved right gastric vessels. The length of the tube was consistent with the greater curvature of the residual stomach. The reconstructed gastric tube was lastly anastomosed with the proximal esophageal end.

(Reference: Chen XF, Zhang B, Chen ZX, Hu JK, Dai B, Wang F, Yang HX, Chen JP. Gastric tube reconstruction reduces postoperative gastroesophageal reflux in adenocarcinoma of esophagogastric junction. Dig Dis Sci. 2012;57(3):738-745.)

Gastric tube anastomosis

Double-track anastomosis group: First, cut off the jejunum about 15-20 cm away from the Treitz ligament; Second, Roux-en-Y esophagojejunostomy (E-J stomy, first anastomosis) was perform by 25mm circular stapler device; Third, from 30-40cm to the E-J stomy, perform the side-to-side gastrojejunostomy (G-J stomy, second anastomosis). Forth, from 25-30cm to the G-J stomy, perform the jejunojejunostomy (J-J stomy, third anastomosis).

(Reference: Ahn SH, Jung do H, Son SY, Lee CM, Park do J, Kim HH. Laparoscopic double-tract proximal gastrectomy for proximal early gastric cancer. Gastric Cancer. 2014;17(3):562-70.)

Double-track anastomosis

Gastric cancer as one of the most common gastrointestinal cancers, radical resection of primary lesions combined with dissection of regional lymph-nodes is acknowledged by surgeons all over the world. When compared with the advanced upper third gastric cancer, proximal gastrectomy has been acknowledged as the standard therapeutic strategy for the early gastric cancer located in the upper third of the stomach. However, due to abandon the anti-reflux barrier of the digestive system caused by the dissection of the cardia and the lower esophageal sphincter, the belching、hiccup、Acid reflux、heartburn、chest pain symptoms and as well as the reflux esophagitis caused by the traditional esophagostomy permanently influence the postoperative quality of life for those patients. Nowadays, relationship between the digestive track reconstruction for proximal gastrectomy and the postoperative quality of life is still with controversies. Previous study reported the gastric tube anastomosis can minimize the reflux related symptoms when compared with traditional esophagogastrostomy. There still exited some patients need long-term anti-acid drug to control the reflux symptoms although underwent the gastric tube anastomosis. The double-track anastomosis for proximal gastrectomy may successfully control the reflux symptoms and there existed study found it is as safe as the esophagostomy. But there has no randomized control study to compare the postoperative quality of life between the gastric tube anastomosis and double-track anastomosis for proximal gastrectomy.

By the reasons above, a randomized controlled trial is conducted with the intention to compare the intraoperative and postoperative mortality and morbidity and the postoperative quality of life between the esophagogastrostomy and the double-track anastomosis in the proximal gastrectomy for gastric cancer patients.

Standard Operating Procedure (SOP)

1. Preoperative evaluation Patients satisfied with inclusion/exclusion criteria will be informed to join in the clinical study and signature the inform consent.
2. Randomization: Intraoperative evaluation found that R0, proximal gastrectomy can be performed, the case will entrance into the Randomization period. Random numbers are computer-generated, with the third party applications.
3. Surgical procedures: The surgical treatments is adopted the proximal gastrectomy according to the Japanese Gastric Cancer treatments guidelines, 2010, Version 3. Group A take the gastric tube anastomosis and Group B take the double-track anastomosis (the reconstruction method is described in the intervention section of study groups). The two study will take the similar surgical procedures except for the digestive track reconstruction.
4. Postoperative recovery: Postoperative recovery period need to collect those relevant parameters of all the patients. All the relevant parameters had definitely definition in the Case Report Form of this study which included the preoperative, intraoperative and postoperative clinicopathologic characteristics.
5. Follow-up: The follow-up of this study divide into two parts, the postoperative quality of life and tumor characteristics outcomes. The information of the postoperative quality of life is collected by the European Organization for Research and Treatment of Cancer (EORCT) QLQ-C30 and STO-22 questionnaires. At the postoperative 12 moths, the upper gastrointestinal scope is needed to examine the reflux esophagitis and the remnant gastritis according to Los Angeles Classification of esophagitis. The tumor related outcomes included long-term postoperative complications, recurrence type, relapse free survival (months) and the overall survival (months).

Double Tract Anastomosis and Gastric Tube Anastomosis to Proximal Gastrectomy

Remnant Stomach-jejunum Double Tract Anastomosis vs. Gastric Tube Anastomosis to Proximal Gastrectomy of Early Gastric Cancer- a Randomized Controlled Trial

Evaluated by Los Angeles classification. Reference: Lundell LR, Dent J, Bennett JR, et al. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut 1999; 45: 172-80.

Jian-Kun Hu

Vice director of the Gastrointestinal Surgery Derpartment

Total Gastrectomy or Proximal Gastrectomy

Wang Ya Nong, MD, PhD

Huang Hua, MD,PhD

Ya Nong Wang, MD,PhD

Hua Huang, MD,PhD

The purpose of this study is to find out more about differences of the quality of life in patients undergoing total gastrectomy or proximal gastrectomy for adenocarcinoma of esophagogastric junction. To find a better reconstruction for patients who received total gastrectomy.

Overall, the incidence of stomach cancer worldwide is declining with geographical variation. However, an increase in the incidence rate of adenocarcinoma of esophagogastric junction, called cardia or AEG has been observed in recent years. AEG may represent a specific histopathological and biologic entity. In the treatment AEG there is argument over whether proximal gastractomy(PG) or total gastractomy (TG) should be done. The quality of life (QOL) of the patients following TG or PG arouses people's attention. The purpose of this study was to evaluate differences of the quality of life in patients undergoing total gastrectomy or proximal gastrectomy for adenocarcinoma of esophagogastric junction.

Impact on Quality of Life in Patients Undergoing Total Gastrectomy or Proximal Gastrectomy for Adenocarcinoma of Esophagogastric Junction

A Pilot Randomized Controlled Trial Examining the Differences of Quality of Life of Patients Undergoing Total Gastrectomy or Proximal Gastrectomy for Adenocarcinoma of Esophagogastric Junction

From preoperative following gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal Gastrectomy	NCT05539105	Proximal Gastri... Reconstruction	Double tract re... Gastric conduit... Other reconstru...	18 Years - 80 Years	Shanghai Zhongshan Hospital
Laparoscopy-assisted Proximal Gastrectomy Versus and Laparoscopy-assisted Total Gastrectomy	NCT01433861	Gastric Cancer	Laparoscopy-ass...	20 Years - 80 Years	Seoul National University Bundang Hospital
Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy	NCT06354036	Gastric Cancer	the Transhiatal...	18 Years - 80 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy	NCT06354036	Gastric Cancer	the Transhiatal...	18 Years - 80 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique	NCT06300879	Gastric Cancer Adenocarcinoma ...	Performing tota...	18 Years - 75 Years	Huashan Hospital
A Clinical Study of Laparoscopic Proximal Gastrectomy Based on PTST(Parachute-tunnel- Style Technique) Esophagogastric Anastomose.	NCT06217991	Gastroesophagea... Proximal Gastre... Gastroesophagos...	PTST(parachute-...	18 Years - 70 Years	Tang-Du Hospital
Double Tract Anastomosis and Gastric Tube Anastomosis to Proximal Gastrectomy	NCT02288728	Complications Quality of Life Remnant Gastrit... Reflux Esophagi...	Gastric tube an... Double-track an...	18 Years - 75 Years	West China Hospital
Impact on Quality of Life in Patients Undergoing Total Gastrectomy or Proximal Gastrectomy for Adenocarcinoma of Esophagogastric Junction	NCT01697917	Adenocarcinoma ...	Total Gastrecto...	20 Years - 75 Years	Fudan University
Laparoscopy-assisted Proximal Gastrectomy Versus and Laparoscopy-assisted Total Gastrectomy	NCT01433861	Gastric Cancer	Laparoscopy-ass...	20 Years - 80 Years	Seoul National University Bundang Hospital

Spots Global Cancer Trial Database for proximal gastrectomy