Clinical trial NCT04663789: Routine Staple Line Reinforcement for Minimally Invasive Distal Pancreatectomy
Official title: Efficacy of Routine Staple Line Reinforcement Versus no Reinforcement on Pancreatic Fistula After Minimally Invasive Distal Pancreatectomy: A Single Center, Parallel, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreas Neoplasm
Stump
Surgery--Complications
Keywords: Staple line
Reinforcement
Pancreatic fistula
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Clinically relevant postoperative pancreatic fistula (CR-POPF)
timeFrame: Postoperative postoperative day 30.
Secondary outcomes:
measure: Operative time
timeFrame: Postoperative postoperative day 30.
measure: Estimated blood loss
timeFrame: Postoperative postoperative day 30.
measure: Length of postoperative hospital stay
timeFrame: Postoperative postoperative day 30.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Junchao Guo, Doctor
role: STUDY_DIRECTOR
References: