Routine Staple Line Reinforcement for Minimally Invasive Distal Pancreatectomy

NCT04663789 | Unknown

• 1 other identifier: PUMCHTF2
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreas Neoplasm; Stump; Surgery--Complications

Keywords

Staple line; Reinforcement; Pancreatic fistula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Operative time

  Postoperative postoperative day 30.

• Estimated blood loss

  Postoperative postoperative day 30.

• Length of postoperative hospital stay

  Postoperative postoperative day 30.

Study Arms (2)

Staple line plus reinforcement

EXPERIMENTAL

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

Procedure: reinforcement of the staple line

staple line with no reinforcement

OTHER

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

Procedure: staple only

Interventions

reinforcement of the staple line PROCEDURE

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

Staple line plus reinforcement

staple only PROCEDURE

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

staple line with no reinforcement

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

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

• Junchao Guo, Doctor

  Peking Union Medical College Hospital

  STUDY DIRECTOR

Central Study Contacts

Feng Tian, Doctor

CONTACT

+86-01069152600; andytianfeng@126.com

Jun Lu, Doctor

CONTACT

+86-01069152601; pumchtf@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: It will be single blinded. Operator, first assistant and data collector could not be blinded. Whereas patients, nurses, data analyzer, and those who have the access to the primary predictor will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending

Model Details: The study is a single-center, randomized controlled clinical trial. Grouping: the study group is set as "staple line plus reinforcement" group, in which a lock stitch will be placed after transecting the pancreas with stapler. While the control group is set as "staple line with no reinforcement" group, in which no additional reinforcement is used after transecting the pancreas with stapler.

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 11, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: May 30, 2023
• Last Updated: February 12, 2021

Record last verified: 2021-02

Locations

CN (1)