Neoplasms

Digestive System Diseases

All Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Rare Diseases

Stomach Neoplasms

Esophageal Neoplasms

Pancreatic Neoplasms

Weight Loss

Malnutrition

Body Weight

Duodenal Neoplasms

Body Weight Changes

Nutrition Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Intestinal Neoplasms

Duodenal Diseases

Intestinal Diseases

Stomach Cancer

Esophageal Cancer

Pancreatic Cancer

All Drugs and Chemicals

Gastrointestinal Agents

Antineoplastic Agents

Hormones

Glucagon

Somatostatin

Glucagon-Like Peptide 1

Octreotide

Antineoplastic Agents, Hormonal

Double-blind single dose octreotide-placebo crossover

Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen

Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen

Placebo

John V Reynolds, MCh, FRCS

Improvements to treatment strategies for patients with cancers of the upper gastrointestinal tract have produced a large population of people who remain free from cancer recurrence in the long term following treatment.

Surgery is the cornerstone of treatment for patients with these cancers, but while surgical removal of the tumour may offer the best chance of cure, these are major operations associated with specific long term complications. Weight loss and poor nutrition are common problems among patients who attain long-term cancer remission and cure after surgery. The mechanisms underlying these problems are not well understood and therefore treatment options are limited.

Our research has demonstrated increased levels of chemical messengers (gut hormones) released from the gastrointestinal tract after meals in patients who have previously undergone this type of surgery. These chemical messengers play a role in controlling appetite and interest in food, and increased levels after surgery may reduce interest in eating. Understanding the role of gut hormones in the control of appetite may allow us to use certain medications to block gut hormones and hence increase appetite, allowing patients to eat more and regain weight, preventing nutritional problems after surgery.

In this study, the investigators aim to determine whether exaggerated gut hormone secretion causes reduced appetite and interest in food after surgery. The information gained from this study may help us to develop treatments for patients with weight loss and nutritional problems after surgery.

The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery

University College Dublin

University of Dublin, Trinity College

Göteborg University

St. James's Hospital, Ireland

Surgical Research Fellow

Fistula

Pancreatic Fistula

Digestive System Fistula

Pathological Conditions, Anatomical

Pancrelipase

Pancreatin

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

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

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

reinforcement of the staple line

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

staple only

Feng Tian, Doctor

Jun Lu, Doctor

Junchao Guo, Doctor

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.

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.

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.

Routine Staple Line Reinforcement for Minimally Invasive Distal Pancreatectomy

Efficacy of Routine Staple Line Reinforcement Versus no Reinforcement on Pancreatic Fistula After Minimally Invasive Distal Pancreatectomy: A Single Center, Parallel, Randomized Controlled Trial

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.

Peking Union Medical College Hospital

Attending

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery	NCT02381249	Esophageal Neop... Stomach Neoplas... Weight Loss Malnutrition Pancreatic Neop... Duodenal Neopla...	Octreotide Placebo	18 Years - 100 Years	St. James's Hospital, Ireland
Routine Staple Line Reinforcement for Minimally Invasive Distal Pancreatectomy	NCT04663789	Pancreas Neopla... Stump Surgery--Compli...	reinforcement o... staple only	18 Years - 80 Years	Peking Union Medical College Hospital
Routine Staple Line Reinforcement for Minimally Invasive Distal Pancreatectomy	NCT04663789	Pancreas Neopla... Stump Surgery--Compli...	reinforcement o... staple only	18 Years - 80 Years	Peking Union Medical College Hospital
The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery	NCT02381249	Esophageal Neop... Stomach Neoplas... Weight Loss Malnutrition Pancreatic Neop... Duodenal Neopla...	Octreotide Placebo	18 Years - 100 Years	St. James's Hospital, Ireland

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