Routine Staple Line Reinforcement For Minimally Invasive Distal Pancreatectomy

Study Overview

Routine Staple Line Reinforcement for Minimally Invasive Distal Pancreatectomy

Postoperative fistula is the major complications of distal pancreatectomies which prohibit patients' recovery. Previous studies have reported controversial results regarding the efficacy of pancreatic stump reinforcement methods. Prior research has commonly included minimally invasive and open cases together. Moreover, stapler and suture were combined in most studies making interpretation difficult. Data has shown that staple line plus reinforcement might potentially decrease the CR-POPF rate of patients who underwent distal pancreatectomies, but well-designed high-quality evidence is lacking. Thus, the investigators design the present study to the question that whether routine staple line plus reinforcement would bring benefit for participants.

Distal pancreatectomy (DP)is the standard surgical method for benign or malignant pancreatic tumors locating at body and tail [1]. Clinically relevant postoperative pancreatic fistula (CR-POPF) is the major complication after pancreatectomy. In literature, reported CR-POPF rate after distal pancreatectomy varied between 5% and 64% from different centers. It's still a challenge to prevent CR-POPF via effective pancreatic remnant closure and no consensus on the optimal surgical technique has been established. Reported surgical strategies to prevent CR-POPF included stapler transection, staple line reinforcement, stump coverage with autologous tissue or fibrin glue, mesh reinforcement, and prophylactic administration of octreotide. However, none had convincing outcome [2-4]. Data has shown that staple line plus suture reinforcement might potentially decrease the CR-POPF rate of patients who underwent distal pancreatectomies, but well-designed high-quality evidence is lacking. Meanwhile, prior researches have commonly included minimally invasive and open cases together. Moreover, stapler and suture were combined in most studies making interpretation difficult [5-8]. Thus, the investigators design a single-centered, parallel, randomized controlled trial to compare the efficacy of routine staple line plus reinforcement versus staple only on the CR-POPF rate of participants who underwent minimally invasive distal pancreatectomies.

Pancreas Neoplasm
Stump
Surgery--Complications

PROCEDURE: reinforcement of the staple line
PROCEDURE: staple only

PUMCHTF2

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-11-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-02-09
First Submitted that Met QC Criteria 2020-12-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-02-12
First Posted (ACTUAL) 2020-12-11	Results First Posted N/A	Last Verified 2021-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Prevention

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Double

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Staple line plus reinforcement In this experimental group, a lock stitch will be placed after transecting the pancreas with stapler.	PROCEDURE: reinforcement of the staple line The operator will perform reinforcement of the staple line with a continuous lock stitch.
OTHER: staple line with no reinforcement In this control group, no additional reinforcement is used after transecting the pancreas with stapler.	PROCEDURE: staple only The operator transect the pancreas with stapler only, without staple line reinforcement.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Staple line plus reinforcement

In this experimental group, a lock stitch will be placed after transecting the pancreas with stapler.

PROCEDURE: reinforcement of the staple line

The operator will perform reinforcement of the staple line with a continuous lock stitch.

OTHER: staple line with no reinforcement

In this control group, no additional reinforcement is used after transecting the pancreas with stapler.

PROCEDURE: staple only

The operator transect the pancreas with stapler only, without staple line reinforcement.

Primary Outcome Measures	Measure Description	Time Frame
Clinically relevant postoperative pancreatic fistula (CR-POPF)	CR-POPF is defined according to the revised 2016 version of ISGPS (International Study Group on Pancreatic Surgery) classification and grading of POPF. A CR-POPF is defined as a drain output of any measurable volume of fluid with amylase level greater than 3 times the upper Institutional normal serum amylase level, associated with a clinically relevant development/condition related directly to the POPF.	Postoperative postoperative day 30.

Secondary Outcome Measures	Measure Description	Time Frame
Operative time	Skin-to-skin time	Postoperative postoperative day 30.
Estimated blood loss	Total blood loss during surgery	Postoperative postoperative day 30.
Length of postoperative hospital stay	Days of hospital stay after surgery	Postoperative postoperative day 30.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Feng Tian, Doctor

Phone Number: +86-01069152600

Email: andytianfeng@126.com

Study Contact Backup

Name: Jun Lu, Doctor

Phone Number: +86-01069152601

Email: pumchtf@sina.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Those who will receive distal pancreatectomy via minimally invasive approaches, no matter benign or malignant;
Aged from 18 - 80 years;
Preoperative diagnosis of serous or mucinous cystic adenoma;
Preoperative diagnosis of solid pseudopapillary tumor (SPT);
Preoperative diagnosis of neuroendocrine tumor;
Preoperative diagnosis of intraductal papillary mucinous neoplasm (IPMN);
Preoperative diagnosis of or pseudocyst;
Preoperative diagnosis of distal pancreatic malignancies;
Patients willing to provide informed consent.

History of upper abdominal surgical history such as splenectomy, gastrectomy, liver resection, duodenal or pancreatic resection (not including laparoscopic cystectomy);
Pancreatic trauma;
With pneumoperitoneum contraindications;
With severe heart or pulmonary diseases which is not fit for surgeries.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Junchao Guo, Doctor, Peking Union Medical College Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record