Comparison of Chen's U-suture Technique with Duct-to-Mucosa Anastomosis and Invagination Pancreaticojejunostomy After Pancreaticoduodenectomy

NCT06863389 | Completed DMC

• 1 other identifier: Chen'sUsuture1
• Study Type: observational
• Target: 5,788
• Locations: 0 countries
• Sites: N/A

Brief Summary

Data of patients treated with pancreaticoduodenectomy in 21 hospitals from January 2014 to December 2019 were retrospectively collected and classified to Chen's group, duct-to-mucosa group and invagination group according to different pancreaticojejunostomy. Propensity score matching analysis was performed to balance the baseline differences among three groups. The surgical outcomes were compared. Independent risk factors for postoperative pancreatic fistula were confirmed by logistic regression analysis, and subgroup analysis was also conducted.

Conditions

Pancreaticoduodenectomy

Outcome Measures

Primary Outcomes (1)

• postoperative pancreatic fistula

  Postoperative pancreatic fistula was diagnosed and graded in accordance with the 2016 update definition of the International study group (ISGPS)

  postoperative 30 days

Study Arms (3)

Chen's group

performing pancreaticojejunostomy by using Chen's U-suture technique

Procedure: Chen's U-suture technique

Invagination group

performing pancreaticojejunostomy by using invagination method

Procedure: invagination

Duct-to-Mucosa group

performing pancreaticojejunostomy by using duct-to-mucosa method

Procedure: Duct-to-Mucosa

Interventions

Chen's U-suture technique PROCEDURE

Initially, an approximately 2 cm cut edge of the pancreas remnant was mobilized and a incision of the jejunal loop was conducted slightly shorter than the pancreatic remnant. Using dual-needle 3-0 prolene suture for anastomosis, needle A went through the entire intestinal wall from the posterior wall about 1.5 cm away from the resection margin of the jejunum loop, then went through the superior boarder of the pancreas from posterior to anterior. To suture the anterior wall of the jejunum loop, the stitch next entered from the resection margin of the jejunum loop and kept it within the seromuscular layer from proximal to distal, and got out from about 1.5 cm away from the resection margin. Needle B repeated the aforementioned procedures with a parallel distance about 1.0 cm between needle A. Generally, the whole anastomosis needed two to four identical stitches. The stitches should overlap each other to reduce pancreatic leakage. Once all the stitches were finished and tighte

Chen's group

invagination PROCEDURE

Firstly, using 3-0 silk sutures, the pancreatic capsule and the serosa of the jejunal loop were anastomosed interruptedly to constitute the posterior outer layer of the anastomosis. Secondly, a jejunotomy with an appropriate size was performed and the inner layer (including posterior and anterior) of invagination was formed by two 5-0 prolene sutures with a continuous running between the pancreatic parenchyma and the full-thickness jejunum. Thirdly, the anterior outer layer was sutured in line with the first step.

Invagination group

Duct-to-Mucosa PROCEDURE

Briefly, Duct-to-Mucosa should make a opening matched to the pancreatic duct and was also performed by two layers. One was the outer layer in both the anterior and posterior walls of the anastomosis which were formed by interrupted 3-0 silk sutures betweent the pancreatic capsule and the jejunal serosa. The other was the inner layer performed in eight to twelve stitches from pancreatic duct to jejunal mucosa with 5-0 prolene sutures.

Duct-to-Mucosa group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who underwent open pancreaticoduodenectomy during the period from January 1, 2014 to December 31, 2019 at 21 hospitals in China were restrospectively recruited. All patients underwent standard open pancreaticoduodenectomy with Child reconstruction which were performed by senior hepato-pancreato-biliary surgeons who performed over 200 pancreaticoduodenectomy per year. According to different PJ, patients were divided into three groups: Chen's, IG, DTM.

You may qualify if:

• open pancreaticoduodenectomy
• Chen's U-suture technique or invagination or duct-to-mucosa anastomosis

You may not qualify if:

• missing data

Sponsors & Collaborators

• Chen Xiaoping: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 7, 2025
• Study Start: January 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-02