Prospective Study on Double-Stapling End-to-End Gastroduodenostomy Billroth-I Anastomosis in Laparoscopy-Assisted Surgery for Locally Advanced Distal Gastric Cancers

NCT05545293 | Unknown DMC

• 1 other identifier: YZhou
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the clinical application value of Double-Stapling End-to-End Gastroduodenostomy Billroth-I Anastomosis in Laparoscopy-Assisted Surgery for Locally Advanced Distal Gastric Cancers.

Conditions

Advanced Gastric Carcinoma

Keywords

anastomotic leakage; laparoscopy-assisted surgery; double-stapling end-to-end gastroduodenostomy; Billroth-I anastomosis; anastomotic stenosis

Outcome Measures

Primary Outcomes (3)

• Anastomotic complications

  The anastomotic complications are defined as the event observed within 30 days after surgery, including anastomotic stenosis, anastomotic bleeding, and anastomotic leakage.

  up to 1-30 Days after surgery

• Intraoperative situation

  Operation time, anastomotic reconstruction time, operative blood loss, completed proportion of laparoscopic surgery, positive rate of Intraoperative frozen margin pathology, anastomotic tension, the distance between proximal and distal of resection margin, the incidence of complication in surgery are used to access the intraoperative situation.

  on the day of surgery

• Postoperative nutritional status and quality of life

  The variation of weight, cholesterol and albumin on postoperative 30 days are used to access the postoperative nutritional status and quality of life.

  up to 1-30 Days after surgery

Secondary Outcomes (4)

• Length of hospital stay

  up to 1-30 Days after surgery

• Cost of hospitalization

  up to 1-30 Days after hospital admission

• Other postoperative complications

  up to 1-30 Days after surgery

• Postoperative intestinal function recovery time

  up to 1-6 Days after surgery

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All eligible patients enrolled in this study would undergo double-stapling end-to-end gastroduodenostomy Billroth-I anastomosis in laparoscopy-assisted surgery

You may qualify if:

• Age from 18 to years (including 18 and 85years old)
• Pathological diagnosis of primary focus is gastric adenocarcinoma made by endoscopic biopsy (papillary, tubular, mucinous, signet ring cell, poorly differentiated)
• cT1-4a, N+/-, M0 at preoperative evaluation
• No peritoneal metastasis or other distant metastases of gastric carcinoma (affirmed by laparoscopic surgery and related imaging examinations)
• Expected curative resection through laparoscopic distal gastrectomy with D2 lymphadenectomy (include multiple primary lower gastric adenocarcinoma)
• Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
• Preoperative American Society of Anesthesiology score (ASA) classⅠ, Ⅱ or Ⅲ
• Major organs are functioning normally:
• blood routine test (No blood transfusions in the last 14 days): HB≥90g/L, ANC≥1.5×109/L, PLT≥80×109/L blood biochemical examination: BIL\<1.5× upper limit of normal (ULN), ALT and AST\<2.5×ULN, Crea≤1×ULN.
• \- The subject is willing to participate in this clinical trail

You may not qualify if:

• History of previous upper abdominal surgery (include ESD/EMR, except laparoscopic cholecystectomy)
• History of acute pancreatitis
• Regional fusion of enlarged lymph nodes by preoperative imaging (maximum diameter \>3cm)
• History of other malignant disease within past five years
• History of unstable angina, myocardial infarction, cerebral infraction, or cerebral hemorrhage within past six months
• History of continuous systematic corticosteroids therapy within past one month
• Requirement of simultaneous surgery for other disease
• Emergency surgery due to complication (bleeding, or perforation) caused by gastric cancer
• FEV1\<50% of predicted values by pulmonary function test
• Women during pregnancy or breast-feeding
• Severe mental disorder
• Participating in other clinical studies simultaneously
• Refusing to sign the informed consent for the study
• Peritoneal implant or other distant metastases by intraoperative exploration
• Unresectable due to tumor reasons by intraoperative exploration

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (10)

• Nishizaki D, Ganeko R, Hoshino N, Hida K, Obama K, Furukawa TA, Sakai Y, Watanabe N. Roux-en-Y versus Billroth-I reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD012998. doi: 10.1002/14651858.CD012998.pub2.

  PMID: 34523717 RESULT

• Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2018 (5th edition). Gastric Cancer. 2021 Jan;24(1):1-21. doi: 10.1007/s10120-020-01042-y. Epub 2020 Feb 14. No abstract available.

  PMID: 32060757 RESULT

• Cai Z, Zhou Y, Wang C, Yin Y, Yin Y, Shen C, Yin X, Chen Z, Zhang B. Optimal reconstruction methods after distal gastrectomy for gastric cancer: A systematic review and network meta-analysis. Medicine (Baltimore). 2018 May;97(20):e10823. doi: 10.1097/MD.0000000000010823.

  PMID: 29768387 RESULT

• Jin HE, Kim MS, Lee CM, Park JH, Choi CI, Lee HH, Min JS, Jee YS, Oh J, Chae H, Choi SI, Lee YT, Kim JH, Huang H, Park S. Meta-analysis and systematic review on laparoscopic-assisted distal gastrectomy (LADG) and totally laparoscopic distal gastrectomy (TLDG) for gastric cancer: Preliminary study for a multicenter prospective KLASS07 trial. Eur J Surg Oncol. 2019 Dec;45(12):2231-2240. doi: 10.1016/j.ejso.2019.06.030. Epub 2019 Jun 22.

  PMID: 31262598 RESULT

• Kanaya S, Gomi T, Momoi H, Tamaki N, Isobe H, Katayama T, Wada Y, Ohtoshi M. Delta-shaped anastomosis in totally laparoscopic Billroth I gastrectomy: new technique of intraabdominal gastroduodenostomy. J Am Coll Surg. 2002 Aug;195(2):284-7. doi: 10.1016/s1072-7515(02)01239-5. No abstract available.

  PMID: 12168979 RESULT

• Lin M, Zheng CH, Huang CM, Li P, Xie JW, Wang JB, Lin JX, Lu J, Chen QY, Cao LL, Tu RH. Totally laparoscopic versus laparoscopy-assisted Billroth-I anastomosis for gastric cancer: a case-control and case-matched study. Surg Endosc. 2016 Dec;30(12):5245-5254. doi: 10.1007/s00464-016-4872-3. Epub 2016 Mar 23.

  PMID: 27008576 RESULT

• Oka M, Maeda Y, Ueno T, Iizuka N, Abe T, Yamamoto K, Ogura Y, Masaki Y, Suzuki T. A hemi-double stapling method to create the Billroth-I anastomosis using a detachable device. J Am Coll Surg. 1995 Oct;181(4):366-8. No abstract available.

  PMID: 7551332 RESULT

• Kuwabara Y, Shinoda N, Sato A, Kimura M, Ishiguro H, Sugiura H, Tanaka T, Ando T, Fujii Y, Fujii Y. Billroth I gastroduodenostomy using a hemi-double stapling technique. J Am Coll Surg. 2004 Apr;198(4):670-2. doi: 10.1016/j.jamcollsurg.2003.11.016. No abstract available.

  PMID: 15051021 RESULT

• Park SH, Kang MJ, Yun EH, Jung KW. Epidemiology of Gastric Cancer in Korea: Trends in Incidence and Survival Based on Korea Central Cancer Registry Data (1999-2019). J Gastric Cancer. 2022 Jul;22(3):160-168. doi: 10.5230/jgc.2022.22.e21.

  PMID: 35938363 RESULT

• Yang HK, Lee HJ, Ahn HS, Yoo MW, Lee IK, Lee KU. Safety of modified double-stapling end-to-end gastroduodenostomy in distal subtotal gastrectomy. J Surg Oncol. 2007 Dec 1;96(7):624-9. doi: 10.1002/jso.20883.

  PMID: 17708549 RESULT

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yusen Cheng, MB

CONTACT

+8615213057290; cysfish@163.com

Yong Zhou, MD, PhD

CONTACT

+8618980605773; nutritioner@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 19, 2022
• Study Start: September 14, 2022
• Primary Completion: August 1, 2023
• Study Completion: December 31, 2023
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)