Shark Mouth Modified Pancreaticojejunostomy

NCT03366038 | Unknown DMC

• 1 other identifier: PekingUTHGS
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreaticoduodenectomy (PD) is one of the most complicated surgical procedure and one of the standard treatments for benign and malignant disease of pancreatic head and periampullary region. Improvements in surgical techniques and the perioperative management of patients undergoing PD have reduced the surgical mortality rates to less than 3% in high-volume medical centers. However, the incidence of postoperative complication remains high, which ranges from 30% to 50% and the pancreatic fistula rate ranges from 5% to 40%. The key point of PD is still the enteric reconstruction of pancreatic stump. There were different techniques of enteric reconstruction, including: invagination pancreaticojejunostomy, binding pancreaticojejunostomy, duct-to-mucosa pancreaticojejunostomy, Roux-en-Y pancreaticojejunostomy, and pancreaticogastrostomy and each technique had its advantages and disadvantages. We established a new digestive reconstruction technique named shark mouth modified pancreaticojejunostomy, which had theoretical advantages including easier performed; lower tension and less complication. The shark mouth modified pancreaticojejunostomy is an end-to-end pancreaticojejunostomy procedure which is between invagination pancreaticojejunostomy and binding pancreaticojejunostomy.The remnant of jejunum is shaped as shark mouth and then sutured with the pancreas remnant. After the surgery, the patients will be well followed up. The pancreaticojejunostomy time, post-operation complication, mortality and hospital stay will be documented to study the safety, efficiency and advantage of this new procedure.

Conditions

Pancreatic Cancer; Periampullary Carcinoma

Keywords

pancreaticoduodenectomy; pancreaticojejunostomy; pancreatic fistula

Outcome Measures

Primary Outcomes (1)

• pancreatic fistula

  The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.

  From 3 days after operation until the date of discharge or date of drains removal, whichever came first, assessed up to 90 days

Secondary Outcomes (4)

• Mortality

  From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 90 days

• Morbidity

  From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 90 days

• pancreaticojejunostomy time

  From the start of intraoperative transverse incision on the posterior wall of the jejunum to the finishing of shark mouth modified pancreaticojejunostomy .

• Hospital stay

  From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 90 days

Study Arms (1)

Modified Pancreaticojejunostomy

Shark Mouth Modified Pancreaticojejunostomy is performed following pancreaticoduodenectomy.

Procedure: Shark Mouth Modified Pancreaticojejunostomy

Interventions

Shark Mouth Modified Pancreaticojejunostomy PROCEDURE

The remnant of jejunum is closed by continuous suture. The transverse incision is made on the posterior wall of the jejunum (5 centimeters distal to remnant）, which starts at 0.2 centimeter to the mesenteric border and should never exceed the anti-mesenteric border . In case of large pancreas remnant, a longitudinal jejunum incision will be done at anterior part of anastomosis. The posterior part of anastomosis is two layers of intermittent suture, including seromuscular suture layer and full thickness suture layer. The anterior part of anastomosis is a single layer full thickness suture. At last, the seromuscular layer of the proximal jejunum is sutured with the anterior pancreatic capsule to cover the anterior part of anastomosis.

Modified Pancreaticojejunostomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients in the Department of General Surgery, Peking University Third Hospital who match to the eligibility criteria will be selected and recruited

You may qualify if:

• Patients diagnosed with pancreatic cancer or other diseases which need pancreaticoduodenectomy
• Operation-tolerated
• Informed consent

You may not qualify if:

• History of abdominal operation
• Pancreaticoduodenectomy is given up during operation
• Patients require to exit from the study anytime
• Pregnancy

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Department of General Surgery, Peking University Third Hospital

Beijing, 100191, China

RECRUITING

Related Publications (3)

• Chen YJ, Lai EC, Lau WY, Chen XP. Enteric reconstruction of pancreatic stump following pancreaticoduodenectomy: a review of the literature. Int J Surg. 2014;12(7):706-11. doi: 10.1016/j.ijsu.2014.05.060. Epub 2014 May 20.

  PMID: 24851718 BACKGROUND

• Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.

  PMID: 28040257 BACKGROUND

• Wang HY, Li MX, Xiu DR. Shark mouth pancreaticojejunostomy: a new enteric reconstruction procedure of pancreatic stump. Chin Med J (Engl). 2019 Jun 5;132(11):1354-1358. doi: 10.1097/CM9.0000000000000219.

  PMID: 30896569 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiu Dainrong, Doctor

  Department of General Surgery, Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang hangyan, Doctor

CONTACT

15611963104; wanghangyan111@163.com

Xiu Dianrong, Doctor

CONTACT

15611908135; xiudianrong7320@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of General Surgery Department

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 8, 2017
• Study Start: December 8, 2017
• Primary Completion: December 9, 2019
• Study Completion: May 1, 2020
• Last Updated: April 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Stating 12 months after publication
• Access Criteria: All the global researchers may get all the individual participant data by sending emai to xiudianrong7320@163.com

Locations

CN (1)