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OpenTrials
Completed

NCT Number: NCT06863389

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • missing data

Treatment and study plan

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

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.

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.

Primary outcomes

  1. postoperative pancreatic fistula

    Time frame: postoperative 30 days

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

Sponsors and collaborators

Lead sponsor

Chen Xiaoping

Other

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2024
First posted
Mar 7, 2025
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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